Microbiological contamination models for use\ud in risk assessment during pharmaceutical\ud production
Whyte, W.; Eaton, T.;
Publisher: Euromed Communications Ltd.
This paper describes the fundamental mechanisms of microbial contamination during manufacture\ud of pharmaceutical products. Models are derived that describe air and surface contact contamination.\ud These models can be used to develop and improve methods of microbial r... View more
1. Guidance for pharmaceutical manufacturers and distributors, ISBN 0-11-322-559-8. The Stationary Office, UK, 2002.
2. ISO 14698-1. Cleanrooms and associated controlled environments - Biocontamination control: Part 1: General principles and methods. Geneva, Switzerland, International Organization for Standardization, 2003.
3. US Food and Drug Administration Centre for Drug Evaluation and Research. Pharmaceutical cGMPs for the 21st Century - a risk-based approach. In: News along the Pike'. August 30, 2002; 1 and 14.
4. IEC 61025-1990, Fault Tree Analysis (FTA). Geneva, Switzerland, International Electrotechnical Commission, 1990.
5. IEC 812-1985, Analysis techniques for system reliability - Procedure for failure mode and effect analysis (FMEA). Geneva, Switzerland, International Electronic Commission, 1985.
6. Kletz T (1999). Hazop and Hazan, ISBN 0852954212. Institute of Chemical Engineers, Rugby, UK.
7. Hazard Analysis and Critical Control Point principles and application guidelines. National advisory committee on microbiological criteria for foods, U.S. Food and Drug Administration, 1997.
8. HACCP - Introducing the Hazard Analysis and Critical Control Point System. Food Safety Unit, World Health Organization. Document number WHO/FSF/FOS/97.2, 1997.
9. Kieffer RG, Bureau S, Borgmann A. Applications or failure mode effect analysis in the pharmaceutical industry. Pharmaceutical Technology Europe, September 1997.
10. Sandle T. The use of risk assessment in the pharmaceutical industry - the application of FMEA to a sterility testing isolator: a case study. European Journal of Parenteral and Pharmaceutical Sciences 2003; 8(2); 43-49.